Contraindications

Precautions

Administration

☞ Know that drug is intended for intratracheal administration and should be given only by neonatologists or other clinicians experienced in neonatal intubation and ventilatory management in facilities with adequate personnel, equipment, and drugs.

☞ Don't dilute drug or shake vial.• Be aware that drug must be drawn into syringe through 20G or larger needle, taking care to avoid excessive foaming. Needle must be removed before drug is delivered through endotracheal tube.

At the Academic Pediatric Society meetings in 2007 in Toronto, a retrospective, epidemiologic paper was presented that reported that Curosurf patients experienced a lower all cause in-hospital mortality than beractant or calfactant patients.

Thus, US neonatologists who wish to use poractant alfa prophylactically have to use it "off label" when there are already 2 lung surfactants, beractant and calfactant, approved for prophylactic use.

Tokyo, Japan, Jan 15, 2008 - (JCN) - Kissei Pharmaceutical today announced that it entered an agreement with New York-based Pneuma Partners LLC concerning research, development and marketing for Calfactant in Japan.

Kissei will attempt to get an early approval of Calfactant for the indication of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) utilizing the results of phase III clinical trial which will be conducted by Pneuma in the US.

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